Biomea Fusion is hiring an Associate Director/Director, Clinical Science to join our growing Clinical Science team. The successful Clinical Scientist contributes to the trial development strategy assisting with protocol development, study design and clinical study execution. In addition, the Clinical Scientist will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies. Industry experience is preferred. The position will report to the Medical Director.
- Assist with the strategy and creation of the clinical development plans for one or more programs.
- Contribute to key strategic documents including clinical development plans, protocol concepts and full protocols for product(s).
- Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
- Review and summarize relevant literatures on the clinical development programs.
- Support investigators meetings and protocol training meetings.
- The Clinical Scientist is responsible for performing ongoing clinical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
- Analyze and interpret study data from an individual study and translating study level clinical data across the program of studies.
- Ensure that all studies are conducted with the highest level of ethical and safety standards in compliance with GCP and all regulatory policies.
- Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and data reviews with investigators.
- Provide support to prepare presentations for advisory boards, steering committee meetings, consultant meetings and investigator meetings.
- Proactively seeking out and recommending process improvements.
- Provide scientific input to the preclinical team for translational studies of interest including biomarker development strategies.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Support authoring/reviewing abstracts, presentations, and manuscripts for external publications.
Education and Experience Requirements:
- Master’s Degree, PhD, or PharmD with clinical trial/drug development experience from Pre-Clinical to Commercial expertise is highly desirable.
- The ideal candidate will have 5+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization.
- Proficient with software tools (Microsoft Office Suite), Adobe, SharePoint, Share Drive, and other custom web-based software used for administrative functions
- Experience authoring new study protocols, CRFs, ICFs, Reports, and other applicable study materials for clinical trial use.
- Experience writing Clinical Study Reports (CSR) with a good understanding of clinical trial operations, clinical trial logistics, and Good Clinical Practices.
- Experience operating effectively within a biotech start-up with complex studies; ability to prioritize tasks and manage multiple priorities and meet deadlines.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.